Overview:
On May 5th, 2022, the FDA announced the availability of a draft guidance for industry entitled Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies. This draft guidance describes the FDA’s recommendations regarding clinical pharmacology considerations for conducting human radiolabeled mass balance studies of investigational drugs, including:
- Deciding whether and when to conduct the study,
- Designing the study
- Reporting results.
Introduction:
A human radiolabeled mass balance study is the single most direct method to obtain quantitative and comprehensive information on the absorption, distribution, metabolism, and excretion of the drug in the human body.
MASS BALANCE STUDIES
The mass balance study can provide information to determine the overall pathways of metabolism and excretion of an investigational drug, identify circulating metabolites, and determine the abundance of metabolites relative to the parent or total drug-related exposure.
Furthermore, results from mass balance studies provide information on which metabolites should be structurally characterized or should undergo nonclinical safety assessment or drug-drug interaction (DDI) evaluation.
Data from such studies can also help determine whether renal or hepatic impairment studies or certain DDI studies are recommended for the investigational drug.
FDA Draft Guidance’s:
The FDA encourages Industry and individuals to comment on the draft guidance. The comments to the draft do make a difference and can impact the outcomes of FDA regulatory policy.
You may submit your comments regarding the draft guidance to the docket (FDA-2022-D-0113) available at https://www.regulations.gov up to 90 days following publication in the FEDERAL REGISTER. This draft guidance, when finalized, will represent the current thinking of the FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public.
Learn more Clinical Pharmacology
The “Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies” guidance is available at: https://go.usa.gov/xupUp. Please refer to the draft guidance for more details.
Brochure : GRP USA Services
We are a global consulting firm Headquartered in Boston Massachusetts USA that provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical and medical device companies worldwide to register their product with the Food and Drug Administration (FDA) the local Health Authority (HA)
Press Release: GRP Inc, Micron Inc. Strategic Alliance
As a preferred Strategic Regulatory partner for world's leading Radiopharmaceutical companies, GRP continues to strengthen its services in Japan. We are excited to share that GRP and Micron Inc, have entered into a strategic partnership to provide Regulatory and Clinical Services in Japan with special focus on Radiopharmaceuticals.
For More Information:
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.